ISO 9001

It’s in the detail

Your implementation guide
ISO 9001 - Quality Management

Background
ISO 9001 is the world’s most popular quality management
system standard and is all about keeping customers satisfied.
Whatever sector you operate in, from manufacturing to
services, companies that work with BSI to adopt the principles
of quality management have benefited from more efficient
ways of working, better cost control and fast and more
effective implementation of new working practices.
This guide tells you in more detail how to embrace and
implement ISO 9001 making it work for your business.
BSI, with our range of services from training to software
solutions, is the perfect partner to help you on your journey
to certification. Let BSI help you gain a competitive advantage.

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Finding your way along the

quality management journey
ISO 9001 needs to work for your business and you will achieve the best results by ensuring that
the system works for you. The management system should not do anything which doesn’t benefit
your business and you’re in control to make it fit for your organization.

Your system needs to show how you consistently deliver products The best way to achieve success within your organization is to build
and services to meet your customer’s needs. This effectively includes a project team and ensure that you communicate to the whole
all the tasks and activities that have to take place throughout the organization to get their buy in and commitment to the project.
organization to deliver your product or service to your customer. It is important that they all understand why you are implementing
You must also continually review and improve the system to ensure the system and the benefits it will bring the organization.
the best performance and that you meet future expectations.
Firstly, you need to understand the standard and the task in hand.
Purchasing a copy of the standard is the way to start as this provides
a lot of information and guidance on implementation. Learn more about the
standards and guides
available from BSI
[Link]/shop
Management
Certified companies
outperform the market by
more than 100%*
=
Share price
Finance Strategic alignment Sales & Marketing
55% achieved 71% acquired new
cost savings customers and retained
= existing clients
Positive impact on =
the bottom line Market access
Product differentiation

Operations ISO 9001 Services

75% improved their
75% boosted their
operational performance Quality levels of customer
satisfaction and loyalty
=
Process efficiency
=
Consumer confidence
Reduced errors
Increased satisfaction
Cost savings
Effective performance management
Business agility

Product Development
Manufacturing cycles reduced by 48%**
=
Increased speed to market
Better quality products

*2011 BSI review of stock prices over a 10 year period, comparing ISO 9001 certified companies with a benchmark index.
**2011 ASQ research. BSI Benefit Survey 2011 † BSI Customer Satisfaction Survey 2012. 3
ISO 9001 - Quality Management

Understanding ISO 9001

ISO 9001 has been designed to be used by any organization, large or small, whatever its products
or services and can be the backbone to creating a more successful business. Here we explain some
of the basics and how to start implementing ISO 9001 so you can reap the benefits.
A management system is simply the way an organization manages its processes, people and
other resources so that its products or services meet their objectives and customer requirements.
For example, your objective may be to ensure that you produce quality products to your customers
or comply with statutory regulations. The system should be both flexible and scalable to your
business and helps embed a culture of continual improvement.
ISO 9001 provides a set of requirements to operate a quality management system and represents
international best practice for managing quality. It is built around eight management principles
that guide and inform everything in it. They are:

Customer focus System approach to management

You need to understand current and future customer needs. When you identify, understand and manage interrelated
You should meet customer requirements and strive to exceed processes as a system, it contributes to achieving your
customer expectations goals and objectives

Leadership Continual improvement

Leaders are responsible for defining the organization’s goals Continually improving your organization ensures that your
and objectives and maintain an environment where people performance will increase and change over time to react
can operate effectively to future challenges

Involvement of people Factual approach to decision making

Everyone in your organization is key to its success and their Effective decisions are based on understanding real
full involvement enables their skills to be used to the maximum data and information and this will help you make the
benefit for themselves and you right decisions

Process approach Mutually beneficial supplier relationships

When activities are seen, understood, managed and delivered Your suppliers can be key to your business and it’s important
through clear business processes, your objectives are more to work closely with them in a mutually beneficial way to create
likely to be achieved value for both organizations.

“We’re very proud that, by achieving

ISO 9001 certification with BSI, we’ve
confirmed our commitment to our staff,
members and travel partners.”
Emma Tickle, Avios CC Global Support Divisional Manager,
Avios UK

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Understanding the Plan-Do-Check-Act principles

The Plan-Do-Check-Act (PDCA) cycle is the operating principle of all ISO management
systems standards, including ISO 9001. By following this cycle, you can effectively
manage and continually improve your organization’s effectiveness.

Plan Check
Establish objectives and draft your plans Measure and monitor your actual results
(analyze your organization’s current systems, against your planned objectives
establish overall objectives, set interim targets
for review and develop plans to achieve them).

Do Act
Implement your plans Correct and improve your plans to meet
and exceed your planned results

Whether you are the Managing Director setting the ROI

Calculator Find out more about our interactive
direction of the business, or an individual focusing
BSI quality ROI calculator and how
on a specific task, the PDCA cycle is very useful in
BSI can help you [Link]/ROI
achieving continual improvement.

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ISO 9001 - Quality Management

Plan – management responsibility

Top level management must be committed to the development and involved
in the implementation of your quality management system. And this part
of ISO 9001 provides you with a powerful planning tool.
These individual requirements take managers through the following activity:

Customer focus Objectives Review the system

Find out what the customer’s current Establish measurable objectives for Review the operation of your system
and future needs and expectations. the organization to help you achieve at regular intervals and improve where
This can be achieved through feedback the aims of the quality policy. necessary. Ensure all appropriate
surveys or talking to some key customers. resources are provided.
Plan the system
Quality Policy Allocate responsibilities and
Use the information gathered from the establish effective processes
customer to write a quality policy that is to achieve your objectives.
relevant and applicable to your organization.

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“Our staff welcomed the implementation

of a consistent and documented
approach and it is evident that the
management system adds value to our
daily operation. ISO 9001 continues to
give us improvements and as a result
we are able to conduct our business
in a more effective and efficient way.”
Suzanne Ralton, Managing Director
Agua Fabrics Ltd

Plan – resource management

The resource management part of the standard makes sure that you review and provide
the resources needed to implement and improve the system.
Resources are looked at in three ways: people, infrastructure and work environment.

People Infrastructure Work Environment

• Decide the competencies and skills This involves the facilities and Here you look at the conditions under
needed within the organization. equipment you need to perform which work is performed and ensure
• Then look at the people you have and effectively. Start by determining that this is appropriate for meeting
identify gaps in existing competencies. and providing what is needed and customers’ requirements. Again,
ensure that you review this regularly. you will need to ensure that this
• Fill those gaps by providing training
is reviewed regularly.
and coaching or encourage self-learning.
• Then go on to see how effective the
actions taken have been in helping you
achieve the necessary competence for
the business.
• Through this technique you always know
whether the training you provide is actually
adding value to the organization and
contributing to results.

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ISO 9001 - Quality Management

Do – Product or service realization

You now have the commitment and direction from management and the necessary
resources to do the job.
ISO 9001 goes on to give you a set of requirements for managing the work you do.
Start with planning and plan the journey from the point where the customer asks
for something, right through to delivery (and beyond if necessary).

Typically this involves Don’t worry if some of the topics here

do not relate to you. Remember ISO 9001
defining the processes for: “When you think of
is designed to be used by all types of
• Sales organizations. You simply concentrate quality, the benchmark
on the areas relevant to you. is the British Standards
• Design and development Institution”.
Make sure at each stage that people
• Purchasing understand their role and are
Tony Peters,
Sales and Marketing Director,
• Production / operational / competent to carry out tasks in line Shades of Comfort
with business policies and procedures.
service activities
• Delivery

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Check and Act – measurement

analysis and improvement
Once you have delivered to your customers, don’t stop! Go on to find out whether they are
satisfied. Take other measurements of the system’s performance, analyse these and identify
the areas for improvement. Again, the standard provides you with a set of requirements for
achieving this using tried and tested techniques.

Customer satisfaction Monitoring and measurement Analysis of data

This really involves the monitoring of of products and processes Using the standard effectively will produce
customer perception. It does not mean that Individual processes drive the system and it is data on how effective your systems are.
you have to send questionnaires to your important that they are operating effectively Use the data to find improvements.
customers. There are many different ways and efficiently. Products should be also
of monitoring perception. You can use measured and monitored to ensure that you
Continual improvement
methods relevant to your business. are meeting the customer’s requirements.
One of the key objectives of the standard
is to make sure that your organization
Internal audit Control of non-conforming improves. Using the results of the analysis
Conduct reviews of your system to make products will help you to determine where those
sure that things are going to plan. If something goes wrong, procedures improvements can be made.
should be in place to ensure the problem
is controlled and dealt with appropriately.

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ISO 9001 - Quality Management

10
tips on making
ISO 9001
effective for you

1 Top management commitment is vital if 6 Clearly lay out a well-communicated plan

the system is to be introduced successfully. of activities and timescales. Make sure
Make sure senior managers are actively everybody understands them and their
involved, approve resources and agree role in achieving them.
the key processes of the business.
7 The nature and complexity of your
2 Review systems, policies, procedures and documentation will depend on the nature
processes you have in place at the moment. and complexity of your organization.
Then compare those with what ISO 9001 ISO 9001 only defines the need for six
asks for. You may be surprised how much procedures. What you have in addition
you already do. The standard will allow you to this is up to you.
to keep the things that work for you while
refining those that don’t. 8 Make the achievement of ISO 9001 engaging
and fun. These will increase motivation.
3 Make sure you have good internal
communication channels and processes 9 Train your staff to carry out audits of the
within the organization. Staff need to be system. Auditing can help with an individual’s
involved and kept informed of what’s development and understanding as well as
going on. providing valuable feedback on potential
problems and opportunities for improvement.
4 Give some thought to how departments
work together. It’s important that the people 10 And lastly if you feel you are doing something
within your organization don’t work in just for the sake of the standard and it doesn’t
isolation but work as a team for the benefit add any value to you as a business – question
of the customers and the organization. whether it’s necessary. Nine times out of 10
it won’t be needed.
5 Don’t ignore the impact that introducing
these systems will have on your customers
and suppliers. Speak to them to gain insight
as to how they view your service and how
they feel improvements could be made.

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“Our integrated management system

continues to be viewed by our clients and
competitors as a best practice guide for the
industry. The disciplines we have embraced
to gain registration have been instrumental
in moving our business forwards.”
Rob Norwell, UK Compliance Manager
Stralfors Plc

“WAYC prides itself on being a “No.1”

provider of services to young people
in Warwickshire. To now be an ISO 9001
awarded organisation underlines this
status and this will enhance our position
in the eyes of prospective funders when
they consider supporting our work.”
Chris Cox, Chair of Trustees
Warwickshire Association of Youth Clubs

“We are continually developing in order to provide

the best service to our customers that we possibly
can. The ISO certification with BSI ensures we
remain committed to developing and enhancing
services, in addition it evidences our approach to
quality which leads to us meeting pre-qualification
questionnaire expectations”
Neil Bancroft, Service Improvement Manager
Peaks and Plains Housing Trust

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ISO 9001 - Quality Management

The key steps in getting

certified to ISO 9001
Make contact

1 We can discuss what you need, and recommend the best services for you. We’ll then give you a proposal
detailing the cost and time involved.

Complete BSI’s application form

2
Once we have received your completed form, we’ll assign you a Client Manager, who will be your point
of contact through the process – and beyond. They’ll have an excellent understanding of your business
area and will support you as you move forward to the assessment and certification of your quality
management system.

Make sure your staff have the necessary skills

3 Whether you’re seeking to implement a management system or would like to increase your general
awareness of the standard, there are a range of workshops, seminars and training courses available
to help you.

Gap analysis to make sure you are on track

4 We can carry out an optional gap analysis, also called a Pre-Assessment, of your existing management
system against the requirements of the standard and identify any omissions or weaknesses that need
resolving before formal assessment.

Formal assessment to achieve your ISO 9001 certificate

5 We’ll do a two-stage assessment. First an initial review of your management system against
ISO 9001 identifying any omissions or weaknesses that need resolving before Stage 2 when
we’ll conduct a full assessment.

Certification and beyond – promote your certificate and your business

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Once the assessment has been successfully completed, we’ll issue a certificate of registration, clearly
explaining the scope of your management system. The certificate is valid for three years, and your assessor
will visit you regularly to help you make sure you remain compliant, and support you in the continual
improvement of your systems.

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BSI supporting you

every step of the way
BSI keeps you informed
BSI s publications draw on a wealth of expert knowledge from across industry. They are particularly
useful when you are getting started. Standards and publications can be purchased individually,
as a kit, or as part of an annual subscription.

The key ISO 9000

publications are: BSI Training
ISO 9000 BSI has a comprehensive range of ISO 9001 training courses.
It describes the fundamentals of quality
Our introductory courses broaden general awareness of customer
management and de nes terms used
in the ISO 9000 quality management focused business practice and our implementing and auditing
family of standards. courses can take that knowledge further.
ISO 9001:2008 We are one of the worlds leading providers of training, information and knowledge on
Is the core document. It speci es standards, management systems, business improvement and the achievement of regulatory
the requirements for a quality approval for products.
management system. We have a team of expert tutors working across the world who can transfer the knowledge,
skills and tools your people need to embed standards of excellence into your organization.
ISO 9004
They have vast amounts of training and assessment experience. They know best how to
It provides guidance to organizations to
transform your organization by training those who can make that change thats how we
support achieving sustained success with
turn our experience into your expertise.
a quality management approach. ISO 9004
is not something you can get a certi cation Visit [Link]/en-ID/Our-services/Training-courses/
for, but it helps businesses turbo-charge or call +6221 8379 3174 - 77 for details.
their ISO 9001 systems.

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ISO 9001 - Quality Management

Entropy Software
Accelerate implementation time and improve continual management of systems.

Whether you are starting your journey BSI Entropy Software provides a powerful Composed of ve core modules and a base
to certi cation, currently implementing management solution that signi cantly system, Entropy Software allows users
management systems or have obtained reduces the cost and effort needed to to add and integrate any number of
certi cation already, ensuring you get proactively manage risk, performance and disciplines into their management process
the most from your investment will be sustainability activities. Entropy Software and provides a complete framework
key drivers to your future success. maps to the requirements of the ISO 9001 in effectively managing risk, audits,
standard for Quality Management Systems performance, incidents, and knowledge
To experience real, long-term bene ts of and provides organizations with the tools across the organization.
certi cation organizations need to ensure necessary to manage essential elements
ongoing compliance to a standard so that of ISO 9001 across your organization -
it becomes an embedded habit. As the all in one solution.
standards expert, BSI makes it easier
for our clients to drive continual Used globally, by companies of all sizes,
improvement and deliver long term Entropy Software provides a number For further information
excellence through our innovative of innovative features that can accelerate please visit
software solution Entropy Software. the time it takes to obtain certi cation and , [Link]
after accelerate: on average by 50% and call +6221 8379 3174 - 77
will also drive continual improvement of
management systems once certi cation
or email
is achieved. [Link]@[Link]

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Use your certi cate to

promote your business
Independent assessment by BSI will assure you and your
key stakeholders that your quality management system
meets the requirements of ISO 9001.
Before the formal certi cation assessments, BSI can
perform a gap analysis (a review of what you do compared
to the standard s requirements) to help identify the areas
that need to be tackled to achieve certi cation smoothly.
When your certi cation has been awarded by BSI you
have a market differentiator that is recognised worldwide.
BSI also works with you to promote your achievement.

For more information visit:

[Link] cation/
or call +6221 8379 3174 - 77
now to start your journey to a more successful business.

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 BSI/UK/134/SC/0213/en/DD
© BSI Group
We know ISO 9001;
BSI shaped the original standard.
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